Recruiting
Phase 2

Pronator Teres Release

Sponsor:

Christine M. Kleinert Institute for Hand and Microsurgery

Code:

NCT01562860

Conditions

Median Nerve Compression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Pronator Teres Release

dual compression release

dual compression release

median nerve release only

Study Details

Brief summary:

The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.

Conditions

Median Nerve Compression

Study ID

NCT01562860

Start date

Jul, 2010

Status verified date

Jan, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

  • Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres
  • Normal two point discrimination
  • Over the age of 18 and under the age of 65

Exclusion Criteria:

  • Peripheral neuropathy of the median nerve secondary to trauma
  • Presence of thoracic outlet syndrome
  • Presence of cervical disk disease
  • Under the age of 18 and over the age of 65

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Carpal Tunnel and Pronator Teres Release

Patients enrolled in this arm of the study will have both surgical procedures performed at the same time

active comparator: Carpal Tunnel Release only

Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.

Interventions

Pronator Teres Release

Surgical release of median nerve compression

dual compression release

Both the carpal tunnel compression and the pronator teres compression will be released on the same day.

dual compression release

both procedures will be done on the same day

median nerve release only

only the carpal tunnel compression is released

Primary outcome measure

  • Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Tuna Ozyurekoglu, MD

502-561-4263tozyurekoglu@cmki.org

Millicent L Horn, BS

502-562-0307mhorn@cmki.org

Locations

Christine M. Kleinert Institute for Hand and Microsurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Christina L Kaufman, PhD

502-562-0390ckaufman@cmki.org

Millicent L Horn, BS

502-562-0307mhorn@cmki.org

Principal Investigator:

Tuna Ozyurekoglu, MD

More Information

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Last update posted

Jan 25, 2018

Last verified

Jan, 2018

Keywords

  • median nerve
  • carpal tunnel syndrome
  • Pronator Teres Release

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine M. Kleinert Institute for Hand and Microsurgery on 2018-01-25.